SR. VALIDATION ENGINEER

Design, develop, and execute validation protocols. Provide validation support for site product development, process improvement, and regulatory compliance initiatives. Assist in generating and reviewing Change Control documents, site validation documents, and site Standard Operating Procedures. Coordinate validation personnel and monitor assignments to assure tasks are completed accurately and on schedule. Maintain current knowledge of federal and state regulations regarding validation and cGMP's and proactively champions validation initiatives to meet same. Assist in establishing, coordinating and championing site Master Validation Plan, schedule, execution of schedule, validation policy and practice. Coordinate validation of Systems, Computers, Lab Methods, Processes, Manufacturing and Laboratory Equipment. Establish and ensure maintenance of training programs for validation personnel.Monitor site validation philosophy, practice, and procedure to ensure the highest standards via continuous improvement. Work with Document Control function to maintain adequate records such as systems and equipment drawings, specifications, protocols, schedules, validation records and reports, etc., as required to establish control of all processes, systems and equipment.Conduct internal audits.Requirements: Bachelor's degree in engineering or related life sciences.5-8 years of validation experience in a finished pharmaceutical environment.Working knowledge of global cGmp’s (to include EU standards) and finished pharmaceutical manufacturing requirements.Validation experience is required in one or more of the following areas: lyophilizers, autoclaves, VHP isolators, computer systems, cleaning, process, fillers, stopper processors, CIP, SIP, ovens, refrigerators, incubators, or HVAC. Results-oriented, able to make decisions and prioritize work per business needs in a fast paced environment. Strong communication, organization and time management skills are necessary.Strong problem solving, decision making, verbal and written communications skills.Proficient in use of Microsoft suite of products. To apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.